A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/26/2017 |
| Start Date: | March 2013 |
| End Date: | April 2017 |
Individuals with bipolar suffer from problems in basic cognitive skills such as memory and
concentration. Unfortunately, there are no current treatments that have been shown to
improve cognitive skills among individuals with bipolar disorder.
Computerized cognitive remediation (CR) is a treatment that has been shown to improve
cognitive skills among individuals with serious mental illnesses other than bipolar
disorder, such as schizophrenia. This treatment involves completing a series of activities
on a computer that have been shown to improve cognitive skills.
D-cycloserine (DCS) is an antibiotic traditionally used in the treatment of tuberculosis.
Recent studies have suggested that this drug may also improve individuals' ability to learn.
Thus, the goal of our study is to examine whether receipt of d-cycloserine increases the
benefit that individuals receive from participation in cognitive remediation.
To test this hypothesis, approximately forty subjects will be randomized to one of two study
arms: [i] CR + DCS or [ii] CR + placebo. We will examine whether d-cycloserine increases the
benefit that individuals with bipolar disorder receive from participation in cognitive
remediation.
concentration. Unfortunately, there are no current treatments that have been shown to
improve cognitive skills among individuals with bipolar disorder.
Computerized cognitive remediation (CR) is a treatment that has been shown to improve
cognitive skills among individuals with serious mental illnesses other than bipolar
disorder, such as schizophrenia. This treatment involves completing a series of activities
on a computer that have been shown to improve cognitive skills.
D-cycloserine (DCS) is an antibiotic traditionally used in the treatment of tuberculosis.
Recent studies have suggested that this drug may also improve individuals' ability to learn.
Thus, the goal of our study is to examine whether receipt of d-cycloserine increases the
benefit that individuals receive from participation in cognitive remediation.
To test this hypothesis, approximately forty subjects will be randomized to one of two study
arms: [i] CR + DCS or [ii] CR + placebo. We will examine whether d-cycloserine increases the
benefit that individuals with bipolar disorder receive from participation in cognitive
remediation.
Individuals with bipolar disorder suffer from a broad array of cognitive deficits that may
hinder their ability to achieve successful community functioning. Consequently, greater
attention has recently been directed toward the development of strategies to ameliorate
these cognitive deficits. One strategy which has been shown to be successful in this
endeavor is cognitive remediation (CR). This intervention, which is recognized as a "best
practice" in the treatment of serious mental illness, is typically comprised of a series of
repeated exercises delivered by a clinician or via a computer that are designed to improve
performance in cognitive functioning. Yet, despite the promise of cognitive remediation, the
benefit of this intervention among individuals with bipolar disorder has yet to be
investigated.
Recently, studies have demonstrated that d-cycloserine (DCS), an N-methyl-D-aspartate
receptor (NMDAR) agonist, may facilitate the learning process for emotional and
non-emotional information in both humans and animals. These results raise the possibility
that DCS may increase the benefits associated with the receipt of cognitive remediation
among individuals with bipolar disorder. To date, we are unaware of any study which has
examined whether concurrent receipt of DCS may increase the benefits produced by cognitive
remediation among individuals with a severe mental illness.
Thus, we propose to complete an exploratory investigation of augmenting cognitive
remediation with DCS among individuals with bipolar disorder. Approximately forty subjects
will be randomized to one of two study arms: [i] CR + DCS; or [ii] CR + placebo. The primary
outcome of interest will be changes in cognitive functioning before and after receipt of the
cognitive remediation intervention. Secondary outcomes of interest will be changes in
symptomatology, social and vocational functioning, and performance of tasks of everyday
living.
hinder their ability to achieve successful community functioning. Consequently, greater
attention has recently been directed toward the development of strategies to ameliorate
these cognitive deficits. One strategy which has been shown to be successful in this
endeavor is cognitive remediation (CR). This intervention, which is recognized as a "best
practice" in the treatment of serious mental illness, is typically comprised of a series of
repeated exercises delivered by a clinician or via a computer that are designed to improve
performance in cognitive functioning. Yet, despite the promise of cognitive remediation, the
benefit of this intervention among individuals with bipolar disorder has yet to be
investigated.
Recently, studies have demonstrated that d-cycloserine (DCS), an N-methyl-D-aspartate
receptor (NMDAR) agonist, may facilitate the learning process for emotional and
non-emotional information in both humans and animals. These results raise the possibility
that DCS may increase the benefits associated with the receipt of cognitive remediation
among individuals with bipolar disorder. To date, we are unaware of any study which has
examined whether concurrent receipt of DCS may increase the benefits produced by cognitive
remediation among individuals with a severe mental illness.
Thus, we propose to complete an exploratory investigation of augmenting cognitive
remediation with DCS among individuals with bipolar disorder. Approximately forty subjects
will be randomized to one of two study arms: [i] CR + DCS; or [ii] CR + placebo. The primary
outcome of interest will be changes in cognitive functioning before and after receipt of the
cognitive remediation intervention. Secondary outcomes of interest will be changes in
symptomatology, social and vocational functioning, and performance of tasks of everyday
living.
- Inclusion Criteria: [i] Diagnosis of Bipolar I or Bipolar II Disorder determined by the
Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental
Disorders (DSM) [ii] Ages 18-65 [iii] No evidence of mental retardation, dementia, or
other organic disorder that may reduce cognitive functioning [iv] premorbid intelligence
quotient (IQ) greater than or equal to 70 as determined by reading subtest of the Wide
Range Achievement Test.
[v] Able to provide informed consent as evidenced by passing the informed consent quiz
with a score of 80% or greater.
[vi] Fluent in English as assessed per self-report from participant [vii] Female subjects
cannot be pregnant or breastfeeding. All subjects must consent to using at least one form
of birth control during study participation.
[viii] Current remission of depressive symptoms as indicated by a score of 8 or less on
the Bipolar Depression Rating Scale.
[ix] Current remission of manic symptoms as indicated by a score of 7 or less on the Young
Mania Scale
Exclusion criteria:
[i] Hypersensitivity to previous receipt of cycloserine per subject report [ii] Epilespy
or history of seizures as assessed using the Medical History form [iii] Meets DSM-IV
criteria for alcohol or drug abuse in the past month or dependence in the past three
months.
[iv] Active suicidal or homicidal ideation [v] Initiation or increase in dosage of any
antidepressant within six weeks, or mood stabilizer within four weeks as assessed using
the Medication Checklist.
[vi] Previous or current participation in cognitive remediation per subject report [vii]
Currently taking d-cycloserine [viii] Reduced kidney or liver functioning, vitamin B12
deficiency, folic acid deficiency, megaloblastic anemia, or sideroblastic anemia per
baseline safety labs.
[ix] Currently taking medication known to have problematic interactions with
d-cycloserine, including etionamide and isoniazid.
[x] History of the blood disease porphyria as assessed using the Medical History form [xi]
Current active symptoms of psychosis defined as not meeting existing guidelines [12] for
remission of psychotic symptoms using the Positive and Negative Syndrome Scale.
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